The intended use of the radiofrequency and microneedling devices used in this study is to assess the efficacy and safety of paired treatment for the treatment of facial aging.
Subjects are to be enrolled in this clinical study if they are a healthy male or female 40 - 65 years of age. Up to 35 subjects will be enrolled at 2 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 4 treatments on the face.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
The entire defined treatment area will then be treated by delivering adjacent pulses with minimal overlap of 10% or less. Parameters may be adjusted throughout the treatment in order to increase subject comfort.
Test spots may be performed prior to the first treatment. Test spots may be performed prior to the first treatment. It will follow a similar procedure to treatment but only in an inconspicuous place, such as behind the ear, in an area no larger than 2in x 2in. The tip will be placed in contact with the skin, and parameters may be adjusted throughout the treatment and will determined by the Clinician.
Center for Dermatology and Laser Surgery
Sacramento, California, United States
New Jersey Plastic Surgery
Montclair, New Jersey, United States
Laser & Skin Surgery Center of New York
New York, New York, United States
Percent of Photos Identified Correctly of 30 Day Follow Up vs. Baseline
The percent of correctly identified photographs (when comparing baseline photos vs. 30 day follow up photos) will be reported.
Time frame: 30 day follow up
Percent of Photos Identified Correctly of 90 Day Follow Up vs. Baseline
The percent of correctly identified photographs (when comparing baseline photos vs. 90 day follow up photos) will be reported.
Time frame: 90 day follow up
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